Senior QC Analyst - Cell Therapy (In-Process & Final Product)

Bristol Myers Squibb; Leiden; On-site; EUR 60,000 - 85,000; Full time

Job summary

Bristol Myers Squibb in Leiden is seeking a Senior Specialist, QC Analytical, Cell Therapy to support QC testing across in-process, final product, and stability samples. You will perform method transfer/validation, data review, and contribute to deviations, CAPA, and continuous improvement.

The role requires training and mentoring others on QC methods (Flow cytometry, qPCR, ELISA, HPLC/UPLC) and adherence to Global Regulatory and cGMP requirements. Two weekends per month work is required.

Qualifications

• Bachelor's degree in science or equivalent.
• 4+ years of QC experience in a regulated environment.
• Experience in cell and molecular biology techniques.

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Anticipate and perform troubleshooting and problem solving with minimal guidance
• Perform data verification, data review and review of GMP documentation for general and complex methods.
• Perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train and mentor others on QC test methods (Flow cytometry, PCR, Cell based assays and HPLC/UPLC), processes and procedures.
• Perform other tasks as assigned.

Skills

QC Testing

GMP Docs

Troubleshooting

Data Review

Flow Cytometry

qPCR

ELISA

HPLC/UPLC

Cell-based Assays

Training Mentoring

Education

Bachelor's degree in science

Bioanalytical science degree

Tools

LIMS

ELN

Job description

Bristol Myers Squibb in Leiden is seeking a Senior Specialist, QC Analytical, Cell Therapy to support QC testing across in-process, final product, and stability samples. You will perform method transfer/validation, data review, and contribute to deviations, CAPA, and continuous improvement.

The role requires training and mentoring others on QC methods (Flow cytometry, qPCR, ELISA, HPLC/UPLC) and adherence to Global Regulatory and cGMP requirements. Two weekends per month work is required.